The Effect of Pelvic Floor Physiotherapy on Vaginal Elast... | NCT04114019

Studies
The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity

NCT04114019

Sponsor

Rambam Health Care Campus

Status

Withdrawn

Last Update Posted

Jul 27, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Stress Urinary Incontinence

Interventions

Vaginal tactile imager

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study device became unavailable for use.

Expanded Access Info

Start Date

Jul 1, 2020Estimated

Primary Completion Date

Dec 30, 2020Estimated

Completion Date

Apr 1, 2021Estimated

First Submitted Date

Oct 1, 2019

First Submission Date that Met QC Criteria

Oct 1, 2019

First Posted Date

Oct 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2020

Last Update Posted Date

Jul 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Women suffering from stress urinary incontinence are offered pelvic floor physiotherapy as an optional treatment. Strengthening of the pelvic floor is measured to date by manual examination and lacks precise evaluation. The vaginal tactile imager assists in evaluation of the changes in the pelvic floor after physiotherapy.

Detailed Description

Women with stress urinary incontinence will undergo 6-10 pelvic floor strengthening physiotherapy sessions. The participants will undergo a short examination of vaginal elasticity using a vaginal tactile imager prior to beginning physiotherapy and additional examinations after 6 treatments, 10 treatments and 3 and 6 months post-treatment cessation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stress urinary incontinence		Women suffering from stress urinary incontinence	Diagnostic Test: Vaginal tactile imager

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaginal tactile imager	Diagnostic Test	Vaginal elasticity evaluation using a vaginal tactile imager	Stress urinary incontinence

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaginal Elasticity	Changes in vaginal elasticity post physiotherapy	From the treatment cessation up to 6 months post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Stress urinary incontinence	Improvement in the urogenital distress inventory questionnaire score (range 0-15)	From the treatment cessation up to 6 months post-treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women suffering from stress urinary incontinence.

Exclusion Criteria:

women suffering from urge urinary incontinence.
women suffering of mixed urinary incontinence.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Women between 18-70 years of age, suffering from stress urinary incontinence, referred to pelvic floor physiotherapy.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Roy Lauterbach, MD	Rambam Health Care Campus	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided